A Phase II Study of Pre-Op SRS Followed by Surgical Resection for Brain Metastases

Last updated: March 3, 2025
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Neoplasm Metastasis

Treatment

Pre-operative Stereotactic Radiosurgery

Clinical Study ID

NCT05341739
2021-240-AGH
  • Ages > 18
  • All Genders

Study Summary

This is a research study to determine if performing stereotactic radiosurgery (SRS) prior to surgical resection of the brain metastasis (tumor) will improve local control, in other words, increase the possibility of total removal of the primary tumor without local recurrence on longterm follow up. This research study will also determine if pre-operative SRS will lower the risk of radionecrosis that is the breakdown of body tissue at the original tumor site, and the development of leptomeningeal disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologic proof or unequivocal cytologic proof of solid tumor malignancy. This maybe obtained from either the primary site or any metastatic site

  2. Solid tumor brain metastases

  3. Age≥ 18 years

  4. Karnofsky Performance Status ≥70

  5. Patient must have agreed to undergo surgical resection to manage at least 1 brainmetastasis

  6. Maximum tumor diameter of index lesions <5 cm. (Index lesion defined as the brainmetastasis which will undergo surgical resection)

  7. Brain MRI within 1 month of initiation of brain SRS

  8. No prior whole brain radiotherapy (WBRT) or radiation therapy directed to indexbrain metastases

  9. Patients of childbearing potential (male or female) must practice adequatecontraception due to possible harmful effects of radiation therapy on an unbornchild

  10. Patient must have the ability to understand and the willingness to sign a writteninformed consent document

  11. All patients must be informed of the investigational nature of this study and mustbe given written informed consent in accordance with institutional and federalguidelines

  12. Patients receiving prior SRS for brain metastases in other locations of the brainare eligible

  13. Patients with multiple brain metastases planned for surgical intervention areeligible for this study. Each individual brain metastasis will be treated

Exclusion

Exclusion Criteria:

  1. Prior WBRT or SRS to the index lesion

  2. Brain metastasis greater than or equal to (≤) 5 cm in maximum diameter

  3. Patients must not have a serious medical or psychiatric illness that would in theopinion of the treating physician prevent informed consent or completion of protocoltreatment, and/or follow-up visits.

  4. Karnofsky Performance Status (KPS) less than (<)70.

  5. Patients with absolute contraindication to MRI imaging are not eligible for thestudy

  6. Patients who are pregnant are excluded from the study.

Study Design

Total Participants: 20
Treatment Group(s): 1
Primary Treatment: Pre-operative Stereotactic Radiosurgery
Phase:
Study Start date:
December 14, 2021
Estimated Completion Date:
November 30, 2025

Study Description

Patients with a solid tumor malignancy that has metastasized to the brain are invited to participate in this trial. Upon enrollment to this study a subject will undergo stereotactic radiosurgery (SRS) using the Elekta Gamma Knife Icon, being treated in once daily 15 minute fractions of 9 Gray (Gy) or every other day 15 minute fractions of 9 Gy for a total dose of 27 Gy in 3 doses. A subject will undergo a routine CT and MRI simulation to determine positioning of the head prior to the start of the SRS treatment. Within two (2) weeks after completion of SRS a subject will undergo a routine surgical resection of the brain metastasis. Prior to the SRS treatment and during the follow up phase of the study MRIs will be performed, which are standard of care. Subjects will also complete a quality of life questionnaire. The duration of subject's time participating in this study is 2 years.

Connect with a study center

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

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